Lower risk Medical device recall · FDA · Published February 3, 2022

Volcano MM-TSM Touch Screen Modules May Crack - Recall

Volcano Corp recalls MM-TSM touch screen modules used with IVUS systems that may crack, causing non-functionality. Affected units have specific part numbers and require replacement of protective beams.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0917-2022Medical device Volcano Corp ›

Lower-risk recall

Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore, bottom protective beams will be replaced with full protective metal brackets.

Take action

Contact the company

Recalling firmVolcano Corp3721 Valley Centre Dr Ste 500 · San Diego, CA 92130-3328

✎ GovInfoNow plain-language explainer

Volcano Corp is recalling MM-TSM touch screen modules that may crack or become damaged when used with IVUS systems, potentially making them non-functional. This could affect medical devices used in healthcare settings. Read more at govinfonow.com/recall/61184-volcano-mm-tsm-touch-screen-modules-may-crack-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/61184-volcano-mm-tsm-touch-screen-modules-may-crack-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0917-2022

Cite this page

“Volcano MM-TSM Touch Screen Modules May Crack - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61184-volcano-mm-tsm-touch-screen-modules-may-crack-recall. Based on FDA recall #Z-0917-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0917-2022%22&limit=1).

The FDA announced on Feb. 3, 2022, that Volcano Corp is recalling MM-TSM Touch Screen Modules due to potential cracking or damage affecting usability. The agency stated the recall is voluntary and ongoing.

How to tell if you have it

Brand: Volcano Corp
Product: MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller)
Part Numbers: 300002018101, 300002018102
Condition: Used with IntraSight Integrated (Part Number: 797403) IVUS systems; MM-TSMs with bottom protective beams

The hazard

The Multi-Modality Touch Screen Modules may crack or become damaged, which may affect their usability and cause them to become non-functional. The recall involves replacing bottom protective beams with full protective metal brackets.

Context

GovInfoNow's records show Volcano Corp has had five other recalls since Jan. 24, 2022. Recent brand recalls include a Philips IntraSight Plus software error dated Aug. 6, 2026, and a Volcano Visions Digital IVUS Catheter recall dated June 13, 2025. Other recent recalls of similar products include a Fresenius Kabi Ivenix Infusion Pump recall (May 6, 2026) and a B. Braun Medical CESK Riverside Health System Software recall (Jan. 29, 2026).

How to tell if you have this one

Check for part numbers 300002018101 or 300002018102 on the MM-TSM modules. These are used with IntraSight Integrated IVUS systems (part number 797403).

Brand
Volcano Corp
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Module Part Number
Identify the part number on the MM-TSM module to confirm if it is affected (300002018101 or 300002018102).
Replace Protective Beams
Replace the bottom protective beams with full protective metal brackets as specified in the recall.

Where it went and when

Where it was distributed

Distributed in 49 states and D.C..

FDA distribution: “US: AZ, IL, NV, MI, FL, NC, AK, PA, WI, MN, CA, AR, NJ, TX, OR, NM, SD, CO, KY, LA, DE, MA, MT, MO, VA, AL, NY, WV, SC, IN, GA, IA, OH, UT, NH, MS, TN, OK, ID, MD, HI, RI, WY, DC, WA, KS, NE, ND, CT, VT. OUS: SK, IT, DK, GB, DE, SE, IN,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 2 months after the firm started it.

Feb 3, 2022Firm started the recall
Apr 12, 2022FDA classified it Class III
Apr 20, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61184-volcano-mm-tsm-touch-screen-modules-may-crack-recall">Volcano MM-TSM Touch Screen Modules May Crack - Recall (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0917-2022 (February 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0917-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.